An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 16-14

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron E. Rippke

Director

SUBJECT: Expansion of the National Centers for Animal Health (NCAH) Portal for

the Center for Veterinary Biologics

I. PURPOSE

The purpose of this Notice is to inform licensees, permittees, and applicants that the 

Center for Veterinary Biologics (CVB) is expanding the functionality of the webbased NCAH Portal by adding to the type of submissions that can be processed. This 

expansion will include APHIS Form 2048, Center for Veterinary Biologics Inspection 

and Compliance E-Submission Form, and APHIS Form 2049, Veterinary Biologics 

Regulatory E-Submission Form Policy, Evaluation, and Licensing.

II. BACKGROUND

The NCAH Portal is external-facing and enables web-based electronic submissions and 

responses between biologics firms and the CVB. The first phase of implementation 

included submissions for APHIS Form 2007, Qualifications of Veterinary Biologics 

Personnel; APHIS Form 2008, Veterinary Biologics Production and Test Report; and

APHIS Form 2020, Shipment and Receipt of Biologics Samples, from all licensees and 

permittees on June 6, 2016, as communicated to stakeholders in CVB Notice No. 16-05. 

III. ACTION 

A. Beginning September 15, 2016, all licensees and permittees may also submit 

most remaining types of correspondence to the CVB through the NCAH Portal 

using APHIS Forms 2048 and 2049. The NCAH Portal replaces hard copy 

submissions and submissions on electronic media, as described in CVB Notice 

No. 13-13. This phase specifically excludes facility documents, export 

certification, Outlines of Production, and Special Outlines.

B. Veterinary biologics establishments must complete the following to gain access

to the NCAH Portal:

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 16-14

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 An Equal Opportunity Provider and Employer

1. Each employee using the NCAH Portal must have a USDA Level 2 

eAuthentication username. Detailed instructions are found at 

https://www.eauth.usda.gov. 

2. Each employee must also have an active APHIS Form 2007 on file with the CVB.

3. Refer to the “Description of Portal Roles” on the CVB Website, which explains 

the NCAH Portal access each role has at 

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/PortalRoles

.pdf 

4. Prior to CVB enabling NCAH Portal access for a licensed firm or permittee, at a 

minimum, each firm must have employee(s) who serve in the following CVBauthorized roles to have full NCAH Portal functionality:

• Liaison or Alternate Liaison

• Government Sampler

There are no changes in the process of the CVB authorization of liaison, alternate 

liaison, or sampler. These CVB authorizations will be processed by the assigned 

Reviewer or Specialist for the firm. 

Other employees from the firm may be added as NCAH Portal users as needed. 

Various roles, having different read/edit/submit privileges, are available.

5. Email CVB at CVB.PIMS@aphis.usda.gov and provide the employee’s name, 

USDA Level 2 eAuthentication username, and NCAH Portal role(s). Firm 

employees can have multiple NCAH Portal roles. CVB will then enter this 

information into the Licensing, Serial Release, and Testing Information System 

(LSRTIS) and reply to the firm when this is completed.

6. There is mandatory annual information security awareness training for each 

NCAH Portal User. Each user will have to complete this security training prior to 

using the NCAH Portal the first time, and once a year thereafter. Information 

security training is available on the homepage of the NCAH Portal. The security 

training completion date will be listed in the “Accounts Details” of the “User 

Info” in the NCAH Portal and includes a link for renewing security training as 

required.

7. Each time an authorized NCAH Portal User logs on to the Portal, they will be 

presented with a warning banner that displays the following information: 

• You are accessing a U.S. Government information system. This 

information system is provided for U.S. Government-authorized use only.

• Unauthorized or improper use of this system may result in civil and 

criminal penalties.
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 16-14

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 An Equal Opportunity Provider and Employer

By using this information system, you understand and consent to the following:

• You have no reasonable expectation of privacy regarding any 

communications or data transiting or stored on this information system. At 

any time, the Government may, for any lawful government purpose,

monitor, intercept, search, and seize any communications or data transiting 

or stored on this information system.

• Any communications or data transiting or stored on this information system 

may be disclosed or used for any lawful government purpose.

• Your consent is final and irrevocable. You may not rely on any statements 

or informal policies purporting to provide you with any expectation of 

privacy regarding communications on this system, whether oral or written, 

by any other official except USDA’s Chief Information Officer.

8. Rules of behavior specific for submitting information via the NCAH Portal 

include the following:

• You will accept all CVB electronic responses via the NCAH Portal and 

understand responses will only be available for 60 days after the CVB 

response is completed.

• Hard copy responses will not be provided by CVB for submissions 

received from the NCAH Portal.

• You will promptly report any information security incidents involving the 

use of the NCAH Portal to the CVB.

C. Submission guidance may be found on the NCAH Portal Guidance page of the CVB 

Website. This page includes user guides, training videos, and other useful 

information regarding the NCAH Portal. 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinarybiologics/sa_ncah_portal_guidance/ct_cvb_portal_guidance

D. The NCAH Portal Website address is 

https://ncahappspub.aphis.usda.gov/NCAHPortal/public/.

E. The CVB will notify users of any scheduled system maintenance or issues by posting 

messages on the home page of the NCAH Portal, as well as on the NCAH Portal 

Guidance page of the CVB Website. 

F. If you experience any technical issues using the NCAH Portal for CVB submissions, 

please email us at CVB.PIMS@aphis.usda.gov. The CVB is willing to schedule 

webinars or conference calls to discuss any specific issues or problems with using 

the NCAH Portal. Teleconferences are highly recommended prior to submitting to 

CVB-Policy, Evaluation, and Licensing using APHIS Form 2049 for those users 

who have not been submitting on electronic media per CVB Notice No. 13-13.
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 16-14

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 An Equal Opportunity Provider and Employer

IV. IMPLEMENTATION/APPLICABILITY

Implementation of the NCAH Portal for APHIS Forms 2048 and 2049 is scheduled to begin 

September 15, 2016. Electronic submission via the NCAH Portal is strongly encouraged, as 

those submissions will be processed by CVB prior to paper-based submissions.